Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
The main objectives of the study:
1. Assess if bednets can be used as rapid, high coverage control method for malaria in urban areas
2. Investigate the effect of ITN introduction on malaria, anaemia and anthropometric measurements
3. Assess the use of haemoglobin level as a measurement of intervention efficacy by controlling for nutritional and geohelminth confounding factors
Ethics approval
1. Liverpool School of Tropical Medicine, UK, approved on 23 September 2002 (ref: 02:50). Some amendments to the existing clearance were reviewed on the 30 April 2004 with additional approval granted on 3rd June 2004.
2. Noguchi Memorial Institute for Medical Research, University of Ghana, Legon, ethical clearance granted in September 2002
Study design
Non-randomised controlled trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Condition
Malaria and anaemia
Intervention
Insecticide treated bednets vs no intervention (Control group received bednets after six months)
It was not possible to randomly allocate children to the two arms of the study as the intervention was community based. The insecticide treated nets were distributed in the intervention community and therefore all children surveyed in that community entered the intervention arm. All households with children under 10 and/or pregnant women in the control community received an insecticide treated nets after six months.
Duration of intervention: 6 months (although the insecticide treated nets remained the property of the study subjects)
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The following were assessed at enrolment, 3 and 6 months:
1. Moderate anaemia, provisionally defined as a haemoglobin level <9 g/dl
2. Haemoglobin level as a continuous variable (in g/dl)
3. Density of infection defined as parasitaemia >5,000 parasites/mm3
Secondary outcome measures
No secondary outcome measures
Overall trial start date
20/05/2004
Overall trial end date
17/12/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Children aged over 1 month and under 10 years
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
600
Participant exclusion criteria
Children with haemoglobin (Hb) <8g/dl who will require iron supplementation
Recruitment start date
20/05/2004
Recruitment end date
17/12/2004
Locations
Countries of recruitment
Ghana
Trial participating centre
Liverpool School of Tropical Medicine
Liverpool
L35QA
United Kingdom
Sponsor information
Organisation
Liverpool School of Tropical Medicine (UK)
Sponsor details
c/o Dr Martin Donnelly
Pembroke Place
Liverpool
L35QA
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
The Department for International Development (DfID) Malaria Knowledge Programme of the Liverpool School of Tropical Medicine (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary